MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK IV SET

Catalog Number	B4020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 3-way high flow stopcock w/rotating luer in which the customer reported that they had an issue with stopcock leaking in the neonatal intensive care unit (nicu).The leak was happening at the point of connection from the stopcock to the iv fluid line.There was no obvious defect noted on the tubing set like cracks or breaks, and no unprotected exposure to the patient, healthcare professional or any other person.The product was used on a patient when the event occurred, however, there was no patient harm reported.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.The device history review was performed and no non conformities were found that would have led the reported complaint.

• Brand Name: 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER
• Common Device Name: STOPCOCK IV SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17843154
• Report Number: 9617594-2023-00776
• Device Sequence Number: 20626455
• Product Code: FMG
• UDI-Device Identifier: 00887709008717
• UDI-Public: (01)00887709008717(17)280401(10)13617861
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: B4020
• Device Lot Number: 13617861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown